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Switching Pharmaceutical Products from Prescription to Over-the-Counter: The Debate in the U.S.

Published online by Cambridge University Press:  20 January 2017

Richard P. Rozek*
Affiliation:
National Economic Research Associates, Inc. (NERA), Washington, D.C.

Abstract

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Type
Reports
Copyright
Copyright © Cambridge University Press 2012

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References

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2 “Utilizing Innovative Technologies and Other Conditions of Safe Use to Expand Access to Nonprescription Drugs,” FDA Hearing, March 22–23, 2012, available on the Internet at <http://www.fda.gov/Drugs/NewsEvents/ucm289290.htm> (last accessed on 31 October 2012). Woodcock, Janet, “Should There be More Flexibility in Our Concept of Non-Prescription Drugs?” Remarks at FDA Hearing on March 22–23, 2012, 3(4) SelfCare (2012), pp.7577 Google Scholar, available on the Internet at <http://selfcarejournal.com/view.article.php?id=10079> (last accessed on 31 October 2012).

3 Temin, Peter, “Costs and Benefi ts in Switching Drugs From Rx to OTC”, 2 Journal of Health Economics (1983), pp. 187205 CrossRefGoogle Scholar. Temin, Peter, “Realized Benefits from Switching Drugs”, 35 Journal of Law and Economics (1992), pp. 351369 CrossRefGoogle Scholar. Jay Patrick Bae, “Economic Analysis of Prescription to Over-the-Counter Conversion of Drugs,” Ph.D., University of California, Los Angeles, 1993. “Advancing Quality Healthcare,” CPHA, available on the Internet at http://chpa-info.org/issues/Quality_Healthcare.aspx (last accessed on 31 October 2012); Kline & Co. “Economic Benefits of Self-Medication, A Final Report to NDMA,” May 15, 1997. CHPA still cites the results of this study. “The Switching Process,” CHPA, available on the Internet at <http://chpa-info.org/scienceregulatory/Switch_Process.aspx> (last accessed on 31 October 2012). Pradel, Francoise, Hartzema, Abraham, Mutran, Elizabeth, and Hanson-Divers, Christine, “Physician Over-The-Counter Drug Prescribing Patterns: An Analysis of the National Ambulatory Medical Care Survey”, 33 The Annals of Pharmacotherapy (1999), pp. 400405 CrossRefGoogle ScholarPubMed. Andrade, Susan, Gurwitz, Jerry, and Fish, Leslie, “The Effect of an Rx-to-OTC Switch on Medication Prescribing Patterns and Utilization of Physician Services”, 37(4) Medical Care (1998), pp. 424430 CrossRefGoogle ScholarPubMed. Sandra Levy, “Increased co-pays open door for wider usage of OTC drugs,” Drug Topics Archive, December 1998, available on the Internet at <http://www.pdr.net/consumer/static.htm?path=content/journals/d/toc/1998d7b.htm> (last accessed on 31 October 2012). “OTC Coverage under Rx May Help Restrain Drug Costs-Ford Exec”, 62(21) The Pink Sheet (2000). “OTC Coverage under Rx May Help Restrain Drug Costs-Ford Exec”, 62(21) The Pink Sheet (2000).

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8 Managed Care Online, http://www.mcareol.com.

9 WellPoint Health Networks, an insurer, fi led a Citizen's Petition with the FDA requesting that Claritin® be switched from Rx to OTC status. Robert Seidman (Chief Pharmacy Offi cer, WellPoint Health Networks), “Petition to Convert Claritin®, Allegra® and Zyrtec® to OTC Status,” presentation to the FDA Pulmonary and OTC Advisory Committee Meeting, May 11, 2001. <http://www.fda.gov/ohrms/dockets/ac/01/slides/3737s_02_seidman.ppt> (last accessed on 31 October 2012).

10 Mickey Smith, “Rx-to-OTC Switches: Refl ections and Projections,” Drug Topics Archive, July 20, 1998, available on the Internet at <http://www.pdr.net/consumer/static.htm?path=content/journals/d/toc/1998d7b.htm> (last accessed on 31 October 2012).

11 Karen Snyder, “The State of the OTC Marketplace,” Drug Topics Archive, June 2, 1997, available on the Internet at <http://www.pdr.net/consumer/static.htm?path=content/journals/d/toc/1997d7b.htm> (last accessed on 31 October 2012).

12 Robert McCarthy, “OTCs: The Wild Card in Cost Effectiveness,” Business & Health, April 1, 1999, p. 33.

13 Medicaid plans vary by state. The rules governing the specific OTC products covered are determined at the state level.

14 The Medicare drug benefi ts are referred to as Medicare Part D.

15 Steven Pray, “OTC Products: Time Limits for Safe Use,” US Pharmacist, 1994, available on the Internet at <http://www.uspharmacist.com/NewLook/DisplayArticle.cfm?item_num=381> (last accessed on 31 October 2012).

16 Woodcock, p. 76.

17 “States Limit Cold Remedy Sales,” Wall Street Journal, August 24, 1998.

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19 Office of Applied Studies, Substance Abuse and Mental Health Services Administration, TEDS – 1.30.99.

20 Office of Applied Studies, “Year-End 1998 Emergency Department Data from the Drug Abuse Warning Network,” Department of Health and Human Services, 1998, p. 23.

21 Year-End 1998 Emergency Department Data from the Drug Abuse Warning Network, p. 23.

22 Year-End 1998 Emergency Department Data from the Drug Abuse Warning Network, p. 23.

23 John Fischman, “Herbs and Prescriptions Can Make a Risky Mixture,” U.S. News and World Report, May 1, 2000, p. 64.

24 “Over-the-Counter Drugs: Safe if Used Wisely”, 2(6) National Policy and Resource Center on Women and Aging Letter (1998).

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26 Honig and Gillespie, p. 170.

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29 Christopher Hollenbeak, p. 667.

30 Bae, p. 8.

31 Bae, p. 9.

32 Ryan and Yule, p. 238.